Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application for a 500mg chewable tablet formulation of mebendazole. If approved, mebendazole chewable tablets will provide a treatment alternative for adults and children aged one year or older with single or mixed soil-transmitted helminthiasis (STH), and address an unmet need for children too young to swallow a solid tablet.

This submission responds to recommendations by the World Health Organization (WHO) calling for a more child-friendly formulation of mebendazole to effectively treat young children, their families and communities. Specifically, the WHO recommends only chewable deworming tablets be given to children under five years, and that chewable tablets be mixed with water in children under three years.1

“At Janssen, we are committed to developing innovative treatments which address unmet public health needs,” said Wim Parys, M.D., Global Head of R&D, Global Public Health, Janssen. “This filing brings us closer to a chewable mebendazole tablet as a potential option for young children and adults in the treatment of intestinal worms. The tablet can be chewed by children over five years without a need for potable water. When mixed with water, it forms a soft mass, allowing the treatment to be extended to children as young as one year of age who cannot be given a solid tablet.”

If approved, Johnson & Johnson aims to replace its current mebendazole solid tablet with the 500mg chewable tablet in the VERMOXTM(mebendazole) donation program, providing free access to this treatment for people in high burden countries.

The FDA submission is supported by data from 712 patients across four clinical trials2 in children and adults with single or mixed intestinal worm infestations. The results of these trials are consistent with the safety and efficacy of all currently registered mebendazole dosage forms which have been used for more than 45 years.

About soil-transmitted helminthiasis

Soil-transmitted helminthiasis (STH) is among the most common infections worldwide, affecting the most deprived communities. STH is transmitted by eggs present in human faeces which can contaminate soil in areas where sanitation is poor.3

Approximately two billion people are infested with STH worldwide. STH can infect both children and adults, however children are more at risk. Over 270 million preschool-age children and more than 600 million school-age children live in endemic areas and are in need of treatment and preventive interventions. The most common species that infect people are the roundworm, whipworm and hookworm.3

STH is considered a Neglected Tropical Disease by the WHO and FDA.4 To help lower the disease burden, the WHO recommends mass drug administration (MDA) programs are carried out on a routine basis (for example twice a year) for at-risk people, particularly children, living in endemic areas.3

The mebendazole 500mg chewable tablet is an oral, rapidly disintegrating tablet that is in development for the treatment of STH in adults and children aged over one year.Mebendazole interferes with cellular tubulin formation in intestinal worms which leads to the death of the worm.

The tablet can be chewed by children over five years without the need for potable water. With a small amount of water, the tablet can form a soft mass which can be swallowed by children as young as one year who cannot be given a solid tablet.

Janssen’s current 500mg single-dose VERMOX™ (mebendazole) tablet is indicated for the treatment of single or mixed intestinal infestations by Trichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm) and Ancylostoma duodenale and Necator americanus (hookworm).

About Johnson & Johnson’s VERMOXTM (mebendazole) donation program

In 2006, Johnson & Johnson founded the Children Without Worms partnership, a collaboration with the Task Force for Global Health, dedicated to the treatment of children with STH. In this partnership, Johnson & Johnson collaborated with the WHO to coordinate a global supply of medicines for intestinal worms and to facilitate distribution of the medicines via MDA programs in schools.

In 2012, Johnson & Johnson endorsed the London Declaration on Neglected Tropical Diseases and continued to expand the VERMOXTM(mebendazole) donation program.

Johnson & Johnson is committed to donating 200 million doses of VERMOXTM (mebendazole) tablets each year through 2020. If approved, the chewable tablet will replace the current solid tablet in donation programs.

For more information about the Children Without Worms program visit: http://www.childrenwithoutworms.org/

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal or @JNJNews.

1 World Health Organization. Preventive chemotherapy in human helminthiasis. Coordinated use of anthelminthic drugs in control interventions: a manual for health professionals and programme managers. Available athttp://apps.who.int/iris/bitstream/10665/43545/1/9241547103_eng.pdf. Last accessed April 2016.

4 Department of Health and Human Services, Food and Drug Administration. Report to Congress: Improving the Prevention, Diagnosis and Treatment of Rare and Neglected Diseases. March 2011. Available athttp://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UCM265525.pdf. Last accessed April 2016.

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